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Posts posted by Dansket
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Are you required by management to implement both systems simultaneously? Do you have separate teams to assign to each project? I would focus on Meditech first and then Immucor after go-Live with Meditech. You can have multiple methods with Meditech, but you should define two sets of T-Tests to manage both manual and automated test results, e.g, anti-A manual and anti-A automated.
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We don't test for negatives on our daily QC for anti-A,anti-B,anti-AB, and A1,B, and A2 cells, as per our manufacturer's package insert. We just had a CAP inspection where we were cited for not doing a negative, but challenged with the package insert and it was accepted.
From the CAP Transfusion Medicine Checklist (07.11.2011):
TRM.31400 Antisera/Reagent Red Cell QC
Records document acceptable reactivity and specificity of typing sera and reagent cells on each day of use, including a check against known positive and negative cells or antisera, or manufacturer's directions for daily quality control are followed.
I assume you used the underlined portion of this CAP requirement to challenge your inspection. I am curious which reagent manufacturer does not require testing for specificity (pos and neg controls) each day of use for anti-A, anti-B or anti-D?
Thanks
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Malcolm,
Appreciate your conversation.
Thanks,
Dan
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Malcolm,
In your laboratory, do you control your anti-A antiserum with A, B and O red blood cells on a daily basis?
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Manufacturer's Instructions for Use state "To confirm the reactivity and specificity of the microtubes containing Anti-A and Anti-B, it is recommended that each lot of cards be tested each day of use with antigen positive and antigen negative red blood cells."
Do you interpret this statement that Anti-A should be tested against group O red blood cells as well as group A red cells and group B red cells to demonstrate reactivity and specificity, i.e., Anti-A agglutinates only group A red blood cells and does not agglutinate group O or group B red blood cells?
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AABB emphasized that if we're using GEL method for crossmatching, there should be another method in place to detect IgM ABO incompatiblity (i.e. tube at IS). If our facility has a computer system in place that detects and alerts ABO incompatiblity between the patient and the donor when selecting the unit for crossmatching (part of our electronic crossmatch process), then does that meet this requirement?
If possible, please direct me to any references that relates to this topic.
Thank you.
The following reference may be pertinent to your question:
2010 Ask the FDA and CLIA Transcript
Ask the FDA and CMS/CLIA
October 11, 2010
AABB 2010 Annual Meeting
Baltimore, Maryland
FDA
- Jay Epstein - Director, Office of Blood Research & Review, CBER
- Ellen Lazarus - Director, Division of Human Tissues in the Office of Cells, Tissue and Gene Therapy, CBER
- Hira Nakhasi - Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
- Paul Mied - Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research & Review, CBER
- Judy Ciaraldi - Consumer Safety Officer, Division of Blood Applications, Office of Blood Research & Review, CBER
- Lore Fields - Consumer Safety Officer, Blood & Plasma Branch, Division of Blood Applications, Office of Blood Research & Review, CBER
- Sharon O'Callaghan - Program Surveillance Branch, Office of Compliance & Biologics Quality, CBER
CMS
- Penelope Meyers - Division of Laboratory Services, Survey & Certification Group, Center for Medicaid & State Operations at CMS
Moderator
- M. Allene Carr-Greer, Director, Regulatory Affairs, AABB
Question 4: We perform all routine testing using gel technology. We also perform electronic crossmatches. For patients in whom clinically significant antibodies have been identified, is it sufficient to perform only a gel antiglobulin crossmatch? Does this satisfy the CLIA requirement to perform a test to detect ABO incompatibility?
MS. MEYERS: For this question, before I start, I would like to just make the comment that the answers that I will be giving to the questions today are based on the CLIA regulations. However, I would like to remind the audience that many laboratories choose to obtain their CLIA certification through a CMS-approved accreditation organization, of which there are six. One of which is AABB. These laboratories must follow all the requirements of their chosen accreditation organization which may be more stringent than the CLIA requirements.
Now back to the question. Actually, these CLIA requirements for crossmatching are based on the FDA requirements for crossmatching, and FDA and CMS have collaborated in preparing the answer to this question. The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients.
MODERATOR: Thank you, Penny. Can I ask, because I could not hear everything that you just said, but did you respond to the part about sufficient to perform only the gel antiglobulin crossmatch, that first part?
MS. MEYERS: No, it is not sufficient to perform only the gel antiglobulin crossmatch because that does not fulfill the requirement to detect ABO incompatibilities.
PANEL MEMBERS:
- longhorn2891 and Eagle01
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- Jay Epstein - Director, Office of Blood Research & Review, CBER
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This question is specifically for people who require two blood types on record to transfuse a patient (i.e.: second unique collection to verify blood type).
How many of you guys accept blood type testing records from outside laboratories as a "Retype" confirmation for your pre-admission testing people? The process improvement team from the OR has set their sights on us and in their eyes it is ridiculous that we require people to come specifically to our facility in advance for the type and screen, and draw a second specimen (if no previous history) on the morning of their surgery to verify blood type.
Anyone willing to share their facility's perspective, their personal perspective, or some other useful commentary? :tongue:
Is your Transfusion Service accredited by STATE, CAP, AABB, JCAHO? Your accrediting agency (ies) may require that you possess a current copy of their CLIA license in order to use a specific reference laboratory test result for your facilites patients.
Do you have a Blood Bank computer system? If so, even if the test result form is compliant with the above, how would you get their ABO/Rh into your computer system in a reliable and timely manner? Direct entry of an ABO/Rh from a foreign document into your computer system bypasses all the ordinary checks and balances that your current processes incorporate.
We do a Type and Screen in advance and routinely collect a second blood sample (if indicated on the morning of surgery).
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Just curious--what is used for a negative control for anti-A?
In our facility, ABO typing is done on ProVue. A/B/D Reverse Grouping gel cards are tested against group A1 red cells (positive control) and group B red cells (negative control) using commercially available simulated whole blood controls.
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I have worked in the blood bank for 15 years, and we have always had a policy that if a unit was returned to the blood bank spiked, not transfused, within 30 minutes, we could reissue to that patient within a 24 hour period. My problem is, I cannot find anything in the AABB technical manual, or anywhere else for that matter, that supports our practice. I'm questioning whether we should be doing this...especially since I am now in charge of the blood bank. Does anyone have a policy allowing or not allowing this practice? Thanks
That practice is arbitrary, not evidence-based and cannot be justified with current standards/regulations. The best way to address this issue is to create processes the insure that Nursing does not pick up blood before they have documented patient consent, measured pretransfusion vitals, know that the patient is not scheduled for a procedure, have a patent iv, etc, that is they are truly ready to start the transfusion.
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At a smaller hospital that might keep anti-A1 lectin but have a hard time justifying the cost of A2 reagent cells I want to throw out this logic and let you tear it to shreds:
We run positive controls to allow us to detect a reagent or testing failure causing a false negative result; we run negative controls to allow us to detect when a reagent or testing failure is giving us a false positive result, right? As long as the test of the patient's cells is negative, you can't have a false positive. What you can't truly trust if you are running O cells for a negative control is the positive results you get.
In terms of logic, not regulations, could a place use the lectin with only a positive control and trust the results only if the patient tested negative with the reagent? That is, could they call patients A2 but never call them A1 and be scientifically correct? If the sample tested positive with the lectin they would either have to send the test out for further workup or solve the discrepancy by some other means. ...
In the case of Anti-A1 lectin reagent, the purpose of the controls are to demonstrate that the reagent can correctly distinquish between A1 and A2 cells..
In a facility where appropriate controls cannot be tested and the test is being done to resolve an ABO discrepancy in a patient who may require blood transfsion, one could make a case for that situation to routinely select group O red cells for transfusion. Then send the specimen to a reference lab.
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We've noticed that Kidd antibodies are not being enhanced by the Ortho ficin treated panel cells (multiple lot #s of panels and gel cards). For weak Kidds, the untreated panels are often reactive, while the ficin treated panel is nonreactive. Ortho's package insert recommends using buffer gel cards with the ficin treated cells (Provue will only perform the ficin panel with buffer cards loaded).
After further investigation, we've discovered that performing the ficin panel with IgG gel cards (manually) provides the expected enhanced Kidd antibody reactions. Bottom line, buffer cards are not working according to the manufacturer for Kidd antibodies. Whether the Kidd Ab IgG component structure isn't buffer gel sensitive, Ortho won't speculate. Nor has Ortho admitted to any other record of this occurance.
Has anyone else noticed this phenomenon? Beware
Our Provue (software version 3.2) prompts user to load Anti-IgG gel cards whether the test PanelCFicin-IAT.gru or the test PanelC-IAT.gru is ordered. If the test PanelCFicin-37C.gru is ordered, Provue prompts user to load Buffered Gel cards. Is this not what you're seeing on your ProVue?
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Dansket, Thank you so much your email, helped my IT work through the LIS. Can you please tell me how you are able to reflex the CONFIRM order? Is it attached to the B-type test or the anti-A,B test?
Thank your
Teresa
You are very welcome.
CONFIRM is our name for an LIS Order Group configured as an Order Type of ADD and a Spec Type of NEW. On page 2 of the LIS Order Group dictionary the BBK test entered is also named CONFIRM.
The Anti-A,B test in the BBK Test dictionary is configured for test results of 1+, 2+, 3+ and 4+ defined as positive test results and 0 (zero) is defined as a negative test result. On page 5 of the BBK Test dictionary for the test CONFIRM, the Reflex Order Group CONFIRM is entered for test results 1+, 2+, 3+ and 4+. The test CONFIRMO is entered for a test result of 0(zero). CONFIRM or CONFIRMO is reflexed by Medtech after the user files and saves the test results of the anti-A,B test.
Hope this helps.
Dan
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I have a giant headache that no tylenol can help. We currently backup our patient medical records each day to a specified PC. It appears that if the patient history has had no recent activity, it does not download. Meditech users - How are you making sure that pertinent patient information is available when the computer is down? Thanks!
I use the BBK History Backup Status routine to monitor patient history backup. We have it configured to back up to two different PCs in the Blood Bank. These PCs are always powered-on.
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3rd party payers will not reimburse for the second ABO, they consider it quality control. We don't charge.
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According to AABB Standards for the Computer Crossmatch (5.15.2) the two determinations of the recipient's ABO group (5.15.2.2) require both a forward and reverse type be performed (as specified in 5.13.1) if the computer system is used to detect ABO incompatibility.
Not a problem, we are not AABB accredited
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We are currently doing the ABO retype on all non O's with no current history. However, I have had a lot of trouble trying to get our LIS to allow us to perform only the forward ABO and not the back type nor the RH. We are using a log book currently. It seems everyone else is doing a full type. Are any facilities only doing the forward ABO using Meditech? Pathologists' Regional Laboratory Lewiston, Idaho
Thanks
Teresa
We are using Meditech C/S version 5.64. Currently, we test the uncentrifuged blood sample with anti-A,B on receipt for patients with no ABO/Rh on file. Our Type and Screen (a G-type test) includes a T-type test for entering the result of the anti-A,B serological tube test and BT (a B type test) for ABO/Rh interpretion. A test CONFIRM is configured in Meditech to include results entry for anti-A, anti-B, anti-D and BTU (a B-type test) for the ABO/Rh interpretation. Based on the result entered for the anti-A,B test, either the test CONFIRMO or the test CONFIRM is automatically reflexed when the result is saved and filed. The test CONFIRM is ordered on a new specimen (second venipuncture) to be collected from the patient. That second blood sample is tested with an A/B/D gel card (anti-A, anti-B and anti-D). The results are entered in Meditech and serve as the second ABO/Rh blood type on the patient, satisfying the Meditech requirements for the computer crossmatch. So we have two B-Type tests in our Meditech system, BT and BTU. BTU is also used for donor unit ABO/Rh confirmation tests.
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Just curious to know if you have a reference for your statement. I have always thought that isoton is very viable solvent for rbc's, but maybe 24 hours is truely a long time?
Plain saline has nothing for the red cells to feed on. See page 874-875 of the 16ed of the AABB Technical Manual under heading Method 1-6. Preparing a 3% Red Cell Suspension. See note at the bottom left of page 875.
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I agree with David, but a bit more stringent. Red cells stored in saline at 4C are good for 24 hours maximum.
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We are getting ready to change our crossmatching procedure to only Immediate Spin crossmatches if the antibody screen is negative and the patient does not have history of antibody formation in the past.
I need some good articles to prove to my staff that this is safe. (It is a standard in AABB I know, but they are still leery)
Anyone know any good literature to back this up? Or has anyone seen any good blogs about that on this site. Tried searching and I didn't really see any.
Thanks
Use your crossmatch data for past 12-48 months to make your case. How many patients with a negative antibody screen had incompatible crossmatches? Due to unexpected antibody? Due to ABO incompatibility?
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There are no standards that I'm aware of that would address your issue. Your decision is driven by your internal policies and procedures. In our case, if a patient is known to qualifiy for electronic crossmatch we don't need or physically handle the specimen, just add the order to the existing current Type and Screen in the computer and crossmatch away!
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In this scenario, RN has arrived in Blood Bank with a properly-completed MD-signed facility request form for uncrossmatched red blood cells.
User keys patient identifier into your transfusion services computer system and displays the patient demographics onscreen. User notices that the patient has a history of clinically significant antibody.
At this point, what is your facility’s policy/procedure/practice/response to receipt of a valid request signed by a physician for uncrossmatched red blood cells for a patient with a history of clinically significant antibody?
p Value?
in Education / Quality
Posted
I'm with Malcolm on this, I don't use p values in my antibody identification process.
At my current facility, there is little knowlege of blood banking among the generalists. So I developed a process using a commercially available computer program that automates the antigen rule-out process. Use of this program with a flow chart enables our generalists to come to appropriate conclusions for patient safety, i.e., whether to send specimen to reference lab for antibody identification or limit it to antigen typing.
The above process makes everything transparent and provides me with an audit trail of all the activities associated with antibody identification and at the same time provides the staff with a step-wise process that does not require any memorization. Everything they need to know is on the computer screen and on the flow charting document.